Our client currently has an opportunity for a Junior Validation Engineer to join their team. This is a full time, permanent position offering an excellent salary and benefits package.
The Validation Engineer, plays a key role in the planning and execution of validation activities related to new technologies and process changes. Provides support for the validation activities associated with equipment, test methods & processes ensuring that all compliance issues and requirements of Company validation policies and procedures are addressed. Provides support for the periodic validation reviews and administration of the site validation master plan.
Main Responsibilities of the role
- Ensure validation activities completed comply with US and EU relations, and EHS requirements.
- Drafting documents prepared by project teams (e.g. protocols, reports, change controls).
- Developing validation strategy and validation plan for equipment and process validations.
- Developing sampling plans, test plans and data analysis related to process validation.
- Assist in resolution of deviations/ exceptions during qualification activities.
- Get involved in change control activities in accordance with site procedures.
- Prepare validation documentation for approval.
- Attend identified training, if required, to fulfil the role of Validation Engineer.
- Support the Quality Manager in driving improvements within the Validation and Change Control processes to streamline the validation activities associated with Process Changes, Product Transfers and/or New Product Introductions.
- Process/Quality input for validation processes.
- Adherence to site validation procedures and regulatory requirements.
- Adherence to company procedures as detailed in Quality Manual.
- Support customer and regulatory audits.
Desired Experience and Background of the successful candidate
- Degree Quality/ Manufacturing / Engineering / Science
- Minimum of 2 years’ experience in Quality Assurance/Engineering within regulated industry. Minimum of 1 years’ experience in Process, Equipment and Test Method Validation
- Working knowledge of Quality systems (FDA/ISO) within a regulated environment.
- High understanding of Validation practices including regulatory expectations
- Ability to analyse Capability data using MINITAB.
- Ability to interpret Engineering drawings/specifications.
- Excellent interpersonal & communication skills.